DEVICE: Custom Healthcare Systems Inc. (00811870031571)

Device Identifier (DI) Information

Custom Healthcare Systems Inc.
A3-15679
In Commercial Distribution

Manus Medical, LLC
00811870031571
GS1

1
800604196 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35567 Surgical personnel scrub preparation kit
A collection of devices designed for preoperative preparation of surgical personnel, e.g., scrubbing the fingers, hands and forearms, prior to gloving and donning surgical apparel. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LRO General Surgery Tray
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bb4532ca-65f1-42bc-b5d1-3e4e22dc18bc
June 08, 2023
3
July 30, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20811870031575 20 00811870031571 In Commercial Distribution N/A
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE